Ex Parte Xia et al

Patent Trial and Appeal Board

Jun 29, 2016

12468136 (P.T.A.B. Jun. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/468,136 05/19/2009
23702 7590 07/01/2016
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609
FIRST NAMED INVENTOR
Erning Xia
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
P04764 9391
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
07/01/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
patents@bausch.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERNING XIA, MICHAELE. ALLEN,
STEVEN K. MACLEOD, TAMMY J. KLEIBER, and
GRAIG M. CODY 1
Appeal2013-009171
Application 12/468, 136
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and RICHARD J. SMITH,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an ophthalmic solution. The Examiner rejects the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 According to Appellants, the Real Party in Interest is Bausch and Lomb
Incorporated. (App. Br. 2.)
Appeal2013-009171
Application 12/468, 136
STATEMENT OF THE CASE
The Specification explains that "[ o ]phthahnic compositions are
provided sterile, but once opened, are susceptible to microbial
contamination. In the case of multi-use solutions, the formulations contain
at least a preservative designed to kill microorganisms that come in contact
with the solution" (Spec. 1: i-f 4). "Oxidative preservatives [such as
hydrogen peroxide] ... work by oxidizing cell walls or membranes,
affecting membrane-bound enzymes, and disrupting cellular function ....
At trace concentrations, stabilizers are needed to prevent decomposition of
hydrogen peroxide" (id. at 3: i-f 7).
Claims 1, 3, 4, 6, 7, 14, and 18 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows (emphasis added):
1. An ophthalmic formulation consisting of (a) alginate; (b) a
source of hydrogen peroxide selected from the group consisting
of urea peroxide and sodium perborate; ( c) butylated
hydroxyanisole; (d) glycerine; (e) propylene glycol; (t) a borate
or phosphate buffer; and (g) optionally EDT A; wherein the
source of hydrogen peroxide provides an amount of hydrogen
peroxide in the formulation in a range from about 0.001 to
about 1 percent by weight of the formulation; and wherein the
ophthalmic formulation passes the ISO/DIS 14730 standard
preservative efficacy testing with a 14-day rechallenge.
(App. Br. 7, Claims Appendix.)
Appellants request review of the Examiner's rejection of claims 1, 3,
4, 6, 7, 14, and 18 under 35 U.S.C. §103(a) over Stem2 in view ofKim. 3
2 Stem et al., US 2006/0057105 Al, published Mar. 16, 2006 ("Stem").
3 Kim et al., US 7,485,619 B2, issued Feb. 3, 2009 ("Kim").
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Appeal2013-009171
Application 12/468, 136
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that Stem and Kim teach an ophthalmic
formulation "consisting of' the recited components?
Analysis
The Examiner finds that Stem teaches "an ophthalmic composition for
the treatment of ocular inflammatory allergic condition" (Ans. 4). The
Examiner recognizes that Stem "differs from the claimed invention in the
presence of propylene glycol" (id.). The Examiner looks to Kim for
teaching that "the use of propylene glycol in ophthalmic formulations as old
and well known" and concludes that the ordinary artisan would be motivated
by this teaching to include propylene glycol into Stem's composition (id. at
5).
Appellants contend that "the combination of Stem and Kim does not
teach or suggest any composition that does not include a peroxide stabilizer
of the type of phosphonic acids" (App. Br. 4). Appellants contend that the
claim language excludes "phosphonic acids" (id. at 6). Specifically, "Stem,
by incorporation of Martin's4 disclosure in its entirety, teaches away from
compositions that do not include a peroxide stabilizer of the type of
phosphonic acid or its derivatives" (Reply Br. 5).
The claims recite "[a Jn ophthalmic formulation consisting of' six
required ingredients and one optional ingredient. In addition, one of the
required claim elements provides that the "source of hydrogen peroxide
selected from the group consisting of urea peroxide and sodium perborate."
"[C]losed transition phrases such as 'consisting of' are understood to
4 Martin et al., US 5,725,887, issued Mar. 10, 1998 ("Martin").
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Appeal2013-009171
Application 12/468, 136
exclude any elements, steps, or ingredients not specified in the claim." AFG
Indus., Inc. v. Cardinal JG Co., 239 F.3d 1239, 1245 (Fed. Cir. 2001); see
generally MPEP 2111.03. We agree with Appellants that the claim language
is closed and would exclude peroxide stabilizers.
Stem discloses that preservative components for ocular medicine
formulations include oxidative preservatives (see Stem 6:i-fi-f l 13 and 114) as
well as non-oxidative preservatives (see id. at i-f 115). With respect to
peroxy components, Stem teaches:
examples of oxidative preservative components include peroxy
components. For example, trace amounts of peroxy
components stabilized with a hydrogen peroxide stabilizer, such
as diethylene triamine penta(methylene phosphonic acid) or l-
hydroxyethylidene-1, 1-diphosphonic acid, may be utilized as a
preservative for use in components designed to be used in the
ocular environment. Also, virtually any peroxy component
may be used so long as it is hydrolyzed in water to produce
hydrogen peroxide. Examples of such sources of hydrogen
peroxide, which provide an effective resultant amount of
hydrogen peroxide, include sodium perborate decahydrate,
sodium peroxide and urea peroxide. It has been found that
peracetic acid, an organic peroxy compound, may not be
stabilized utilizing the present system. See, for example,
Martin et al U.S. Pat. No. 5,725,887, the disclosure of which is
incorporated in its entirety herein by reference.
(see id. at i-f 114.)
Martin explains that "[ o ]ne drawback with unstablized dilute
hydrogen peroxide solutions, however, is that without the use of a stabilizer
or a combination of stabilizers, the aqueous peroxide solutions
characteristically decompose over a period of time" especially at elevated
temperatures (Martin 1: 25-28). To avoid decomposition of the hydrogen
peroxide in the ophthalmic solution, Martin includes peroxide stabilizers
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Application 12/468, 136
(see Martin 5: 55 to 7: 15). Martin's formula I (not shown) encompasses
diethylene triamine penta(methylene-phosphonic acid) (id. at 6: 14--16), and
explains that "additional conventional stabilizers may be employed in
conjunction with those of formulae I ... or combinations thereof' (id. at 6:
35-38). In addition, Martin lists conventional stabilizers as including EDTA
chelating agent, glycerin, and propylene glycol (see id. at 6: 35-52).
The Examiner's position is that "Stem does not teach that peroxy
components 'must' be stabilized with a hydrogen peroxide stabilizer. It is
also the examiner's position that the claimed invention uses EDTA, glycerin
and propylene glycol. Such component are considered to be stabilizers of
peroxy components as taught by Martin" (Ans. 5).
Although we recognize the Examiner's position that glycerin,
propylene glycol, and EDT A are recognized by Martin as conventional
stabilizers, we are not persuaded by the Examiner's interpretation that based
on Stem's disclosure there is a suggestion to use peroxy components without
the diethylene triamine penta(methylene phosphonic acid) or l-
hydroxyethylidene-1, 1-diphosphonic acid stabilizers. This is especially true
when Stem's paragraph 114 is read in conjunction with Martin that teaches
the preferred embodiment includes diethylene triamine penta(methylene
phosphonic acid). Martin specifically teaches the use of diethylene triamine
penta(methylene phosphonic acid) for the purpose of stabilizing hydrogen
peroxide in ophthalmic solutions (see Martin's examples). Martin suggests
that the preferred stabilizer can be used in conjunction with conventional
stabilizers. The Examiner, however, has not directed us to sufficient
evidence in the record to suggest that use of conventional stabilizers such as
glycerin, propylene glycol, and EDT A by themselves would be recognized
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Application 12/468, 136
by one of ordinary skill to sufficiently stabilize the hydrogen peroxide
produced by urea peroxide or sodium perborate in an ophthalmic solution.
On balance, based on the evidence presented we find that Appellants have
the better position.
SUMMARY
We reverse the rejection of claims 1, 3, 4, 6, 7, 14, and 18 as obvious
over Stem in view of Kim.
REVERSED
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